Relational Agent to Improve Alcohol Screening and Treatment in Primary Care: RCT

改善初级保健中酒精筛查和治疗的相关代​​理：RCT

• 批准号: 10176177
• 负责人: STEVEN R. SIMON
• 金额: --
• 依托单位: VA BOSTON HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10176177
• 关键词: Acute; Address; Age; Alcohol abuse; Alcohol consumption; Alcohol dependence; Alcohols; Behavior; Behavioral; Boston; Caring; Chronic; Classification; Clinical; Communication Barriers; Complex; Computer Literacy; Computers; Counseling; Coupled; Development; Disease; Drug abuse; Education; Effectiveness; Elements; Ensure; Evaluation; Feedback; Foundations; Frequencies; Future; Goals; Health; Health Promotion; Health Status; Health behavior; Healthcare; Healthcare Systems; Human; Information Technology; Intervention; Interview; Leadership; Measures; Mental Health; Methods; Online Systems; Outcome Measure; Participant; Patients; Performance; Persons; Pilot Projects; Population; Prevalence; Primary Health Care; Provider; Randomized; Randomized Controlled Trials; Reporting; Research; Risk; Schedule; Scheme; Stigmatization; Subgroup; Surveys; System; Tablet Computer; Technology; Telephone; Testing; Text; Time; Touch sensation; Training; Uncertainty; Veterans; Visit; Work; alcohol abuse therapy; alcohol misuse; alcohol screening; alcohol use disorder; arm; base; behavior change; brief alcohol intervention; brief intervention; cognitive interview; computer center; computerized; design; diet and exercise; drinking; eHealth; effective intervention; effective therapy; experience; follow-up; formative assessment; hazardous drinking; health literacy; high risk drinking; improved; innovation; medical specialties; member; motivational enhancement therapy; novel; patient oriented; preference; primary care setting; primary outcome; recruit; response; routine screening; satisfaction; screening and brief intervention; secondary outcome; skills; software development; technique development; technological innovation; tool; touchscreen; treatment arm; treatment as usual; trial comparing; usability

DESCRIPTION (provided by applicant): Background: VA has demonstrated national leadership by implementing electronic clinical reminders and establishing performance measures for both screening and brief intervention for unhealthy alcohol use. Nationally, about 93% of Veterans are screened annually. However, the percentage of brief interventions delivered when needed, and the quality and effectiveness of those interventions, are uncertain. A patient- centered computer-based intervention can help to close the performance gap by delivering a tailored intervention with excellent quality and fidelity Relational Agents are on-screen characters that speak to the patient and establish a "relationship" with them. They have been used to improve several health behaviors including diet and exercise, and can overcome communication barriers related to low levels of computer literacy. The Relational Agent can be placed on a desktop or tablet computer with a touch screen, on which patients indicate their responses. Using Motivational Interviewing and behavior change principles, the Relational Agent guides patients to consider change. Use of such an "eHealth" tool offloads a time-intensive task from the clinician while providing the patient, who may have limited computer skills, a non-threatening vehicle for "discussing" a stigmatized topic such as risky alcohol use. Relational Agents have proven more effective than web-based interventions in promoting health-related behavior changes in some studies. Pilot studies at VA Boston demonstrate that Veterans will engage with Relational Agents and view them favorably. To date, there have been no VA trials of Relational Agents. Aims: The study aims are to 1) Tailor the Relational Agent Intervention to the Veteran population; 2) Conduct a randomized controlled trial of Treatment as Usual plus the Relational Agent versus Treatment as Usual for unhealthy alcohol use; and 3) Examine in-depth Veterans' experience with the Relational Agent Intervention. Methods: To achieve Aim 1, we will use standard software development techniques, including cognitive interviewing and usability testing, to tailor the Relational Agent Intervention to the Veteran population. Once the Relational Agent is refined, we will conduct a two-arm RCT (Aim 2) in the VA Boston Healthcare System. We will randomize Veterans in primary care to Treatment as Usual plus the Relational Agent versus Treatment as Usual, using a stratified randomization scheme to ensure equal numbers of Veterans with unhealthy alcohol use (risky and hazardous drinking) and Veterans with alcohol use disorders (a more severe classification) in each group. Working closely with primary care staff, who routinely screen Veterans for risky alcohol use, we will identify Veterans who screen positive and ask them to participate in the study. We will recruit 180 Veterans over 15 months, with a goal of completing the study with 126 to 144 participants. Veterans allocated to the Relational Agent Intervention arm will interact with the Relational Agent at the time of the primary care visit and will be scheduled for a one-month follow-up visit for a second interaction with the Relational Agent. The Relational Agent will provide personal feedback for the Veteran and the clinician, and will flag Veterans who meet criteria for referral to treatment. Alcohol use and related behaviors will be assessed by in-person survey at baseline and by telephone survey at a 3-month follow-up. Primary outcome measures will be quantity and frequency of alcohol use at the 3-month follow-up, with rates of brief intervention, referral to treatment, and satisfaction as secondary outcomes. Subgroup analyses will allow for examining separately the effects of the Relational Agent on unhealthy alcohol use and on Veterans with alcohol abuse or dependence. Following the RCT, we will conduct a formative evaluation (Aim 3), with in-depth interviews, to characterize the elements of the Intervention that emerge as most effective and those that seem extraneous or even counter-productive. Conclusion: By tailoring a novel eHealth intervention and initiating its evaluation in VA, this study addresses Secretary Shinseki's T21 initiative to employ state-of-the-art technology to improve Veterans' health care.

描述（由申请人提供）： 背景：VA通过实施电子临床提醒并建立绩效措施来筛查和简短干预不健康的饮酒，从而证明了国家领导。在全国范围内，每年约有93％的退伍军人进行筛查。但是，在需要时提供的简短干预措施的百分比以及这些干预措施的质量和有效性尚不确定。以患者为中心的计算机干预可以通过提供出色的质量和忠实关系代理的量身定制的干预措施来帮助缩小性能差距，这是屏幕上与患者交谈并与他们建立“关系”的屏幕字符。它们已被用来改善几种健康行为，包括饮食和运动，并可以克服与计算机识字水平较低有关的沟通障碍。关系代理可以放置在带有触摸屏的台式机或平板电脑上，患者表示他们的反应。利用动机访谈和行为改变原则，关系代理指导患者考虑改变。使用这种“ eHealth”工具可以从临床医生那里卸载一项耗时的任务，同时为患者提供计算机技能有限的患者，这是一种“讨论”污名化主题（例如危险的酒精使用）的无威胁工具。事实证明，在某些研究中，关系代理比基于Web的干预措施更有效。波士顿弗吉尼亚州的试点研究表明，退伍军人将与关系代理人互动，并对他们有利。迄今为止，还没有对关系代理的VA试验。目的：研究的目的是1）针对退伍军人的人口量身定制关系剂的干预； 2）像往常一样对治疗的随机对照试验，以及像往常一样对不健康的酒精使用的关系； 3）检查深入的退伍军人在关系剂干预方面的经验。方法：为了实现目标1，我们将使用标准的软件开发技术，包括认知访谈和可用性测试，以对退伍军人人群进行关系剂的干预。一旦将关系代理完善，我们将在VA波士顿医疗保健系统中进行两臂RCT（AIM 2）。我们将使用分层的随机化方案将初级保健的退伍军人随机治疗，以及像往常一样与治疗一样的治疗，以确保每组不健康的饮酒（风险和危险饮酒）和具有酒精使用障碍（更严重分类）的退伍军人数量相等。与初级保健员工紧密合作，他们经常筛选退伍军人的饮酒风险，我们将确定退伍军人筛选阳性的人，并要求他们参加研究。我们将在15个月内招募180名退伍军人，目的是以126至144名参与者完成研究。分配给关系代理干预部门的退伍军人将在初级保健访问时与关系代理人进行互动，并计划进行一个月的随访，以与关系代理进行第二次互动。关系代理人将为退伍军人和临床医生提供个人反馈，并将标记符合转介治疗标准的退伍军人。酒精使用和相关行为将在基线上的面对面调查以及3个月的随访中通过电话调查进行评估。主要结果指标将是在3个月随访中饮酒的数量和频率，并进行简短干预率，转介治疗以及作为次要结果的满意度。亚组分析将允许分别检查关系剂对不健康饮酒以及对滥用酒精或依赖的退伍军人的影响。在RCT之后，我们将进行形成性的评估（AIM 3），并进行深入的访谈，以表征出现的干预措施，这些要素是最有效的，并且似乎是无关紧要的甚至是适得其反的。结论：通过量身定制一种新型的eHealth干预措施并在VA中启动其评估，本研究介绍了Shinseki秘书的T21倡议，以采用最先进的技术来改善退伍军人的医疗保健。